Brazilian Registry of Menopausal Health

NCT ID: NCT07005648

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1592 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-17
• Study Completion Date: 2026-06-30

Brief Summary

The Brazilian Registry of Menopausal Health is a national study aimed to better understand the health and quality of life of participants aged 35 to 65 who are in the menopausal transition or postmenopausal phase, including cisgender women and transgender men.The study's hypothesis is that significant regional and socioeconomic disparities influence individuals' health, knowledge, and perception of menopause.

Detailed Description

The Brazilian Registry of Menopausal Health, called RENEW (Registry of ENdocrine Changes in midlifE Women), is an observational, cross-sectional, population-based study conducted with the objective of characterizing the epidemiological aspects of the Brazilian population during the menopausal transition and postmenopause, as well as the factors associated with clinical profiles and symptomatology, socioeconomic conditions, social inequalities, access to healthcare services, quality of life, and knowledge about menopause.

The study will include cisgender women and transgender men who have not undergone surgical or hormonal gender reassignment of secondary sexual characteristics, aged between 35 and 65 years, who seek outpatient care in public or private healthcare services.

A total of 1,592 participants will be enrolled, with 617, 509, and 466 participants in the respective age groups of 35-44, 45-54, and 55-65 years, proportionally stratified across the 27 state capitals of Brazil. These age groups will be used solely for the purpose of sample stratification.

Conditions

Menopause

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

617 participants = 35 to 44 years old

No interventions assigned to this group

509 participants = 45 to 54 years old

No interventions assigned to this group

466 participants = 55 to 65 years old

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Women aged between 35 and 65 years attending medical consultation at public and private outpatient health services;

2. Ability to confirm voluntary participation and sign the Informed Consent Form

Exclusion Criteria

1. Inability to respond to the interview for any reason

2. Suspected or confirmed pregnancy

3. Lactation

4. Uncontrolled diabetes

5. Uncontrolled arterial hypertension

6. Uncontrolled thyroid disorders

7. Grade 3 obesity, defined by a BMI equal to or greater than 40.0 kg/m²

8. Diagnosis of psychiatric disorders that may compromise participation in the interview

9. Previous hysterectomy

10. Previous oophorectomy

11. Current use of illicit drugs

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Science Valley Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabiane B de Souza, MD

Role: PRINCIPAL_INVESTIGATOR

Science Valley Research Institute

Locations

Centro de Pesquisa Unidade Morumbi - Science Valley Research Institute

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Leandro Agati

Role: CONTACT

agati@svriglobal.com

+55 (11) 4468-8183

Eduardo Ramacciotti, PhD

Role: CONTACT

ramacciotti@svriglobal.com

+55 (11) 99944-4544

Facility Contacts

Daniele Komar

Role: primary

daniele.komar@svriglobal.com

+55 (11) 4040-8670

References

Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489-501. doi: 10.1016/j.ogc.2011.05.006.

Reference Type: BACKGROUND

PMID: 21961716 (View on PubMed)

Flores VA, Pal L, Manson JE. Hormone Therapy in Menopause: Concepts, Controversies, and Approach to Treatment. Endocr Rev. 2021 Nov 16;42(6):720-752. doi: 10.1210/endrev/bnab011.

Reference Type: BACKGROUND

PMID: 33858012 (View on PubMed)

Mehta J, Kling JM, Manson JE. Risks, Benefits, and Treatment Modalities of Menopausal Hormone Therapy: Current Concepts. Front Endocrinol (Lausanne). 2021 Mar 26;12:564781. doi: 10.3389/fendo.2021.564781. eCollection 2021.

Reference Type: BACKGROUND

PMID: 33841322 (View on PubMed)

Davis SR, Taylor S, Hemachandra C, Magraith K, Ebeling PR, Jane F, Islam RM. The 2023 Practitioner's Toolkit for Managing Menopause. Climacteric. 2023 Dec;26(6):517-536. doi: 10.1080/13697137.2023.2258783. Epub 2023 Dec 1.

Reference Type: BACKGROUND

PMID: 37902335 (View on PubMed)

Oliveira GMM, Almeida MCC, Arcelus CMA, Neto Espindola L, Rivera MAM, Silva-Filho ALD, Marques-Santos C, Fernandes CE, Albuquerque CJDM, Freire CMV, Izar MCO, Costa MENC, Castro ML, Lemke VMG, Lucena AJG, Brandao AA, Macedo AVS, Polanczyk CA, Lantieri CJB, Nahas EP, Alexandre ERG, Campana EMG, Braganca EOV, Colombo FMC, Barbosa ICQ, Rivera IR, Kulak J, Moura LAZ, Pompei LM, Baccaro LFC, Barbosa MM, Rodrigues MAH, Albernaz MA, Decoud MSP, Paiva MSMO, Sanchez-Zambrano MB, Campos MDSB, Acevedo M, Ramirez MS, Souza OF, Medeiros OO, Carvalho RCM, Machado RB, Silva SCTFD, Rodrigues TCV, Avila WS, Costa-Paiva LHSD, Wender MCO. Brazilian Guideline on Menopausal Cardiovascular Health - 2024. Arq Bras Cardiol. 2024 Aug 16;121(7):e20240478. doi: 10.36660/abc.20240478. No abstract available. English, Portuguese.

Reference Type: BACKGROUND

PMID: 39166619 (View on PubMed)

Duralde ER, Sobel TH, Manson JE. Management of perimenopausal and menopausal symptoms. BMJ. 2023 Aug 8;382:e072612. doi: 10.1136/bmj-2022-072612.

Reference Type: BACKGROUND

PMID: 37553173 (View on PubMed)

Other Identifiers

RENEW

Identifier Type: -

Identifier Source: org_study_id